Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075385
Company: IVAX SUB TEVA PHARMS

Products on ANDA 075385

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075385

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/01/2002	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75385ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75388TA.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/06/2008	SUPPL-5	Labeling		Label is not available on this site.
04/27/2005	SUPPL-3	Labeling		Label is not available on this site.